BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3249287 · Received July 26, 2013

    Report

    Report Number
    1030489-2013-03123
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 10, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC COMPLAINT MADE REGARDING THE ASSOCIATED IMPLANTS. VISUAL REVIEW DID NOT IDENTIFY COMPLAINT IDENTIFIED WITH REGARD TO THE RETURNED IMPLANTS. AFTER VISUAL REVIEW, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE ASSOCIATED RETURNED PRODUCT. THE IMPLANTS APPEAR TO BE CAPABLE OF PERFORMING THEIR INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540020, 510K # K052187 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: ON (B)(6) 2010 SHOWS SINGLE PLIF AT L5/S1 WITH METAL INTERBODY SUPPORT. RODS, SPACERS AND SCREWS APPEAR WELL POSITIONED. ON (B)(6) 2012 AP X-RAY SHOWS EXPANSION TO L3 WITH PEDICLE SCREWS AT ALL LEVELS, CROSSLINK BETWEEN L4 AND L5, THE ADDITION OF PLIF SPACERS AT L4/5 AND A CAGE TLIF AT L3/4. DRAIN IS SEEN IN PLACE. NO EVIDENCE OF FAILURE OR MALPOSITION AND NO REASON FOR THE REVISION IS APPARENT. ON (B)(6) 2013 AP X-RAY SHOWS EXTENSION OF CONSTRUCT TO T12 WITH REMOVAL OF THE CAPSTONE AT L3/4 AND THE L3 AND L4 SCREWS. POSITION APPEARS GOOD FOR ALL COMPONENTS OF THE CONSTRUCT. DESCRIPTORS SUGGESTS INTERVAL INFECTION AND NEED FOR DEBRIDEMENT AND METAL REMOVAL. LATERAL VIEW SHOWS GOOD POSITION OF CONSTRUCT WITH NEAR BONE ON BONE DISC NARROWING AT L3/4. SCLEROSIS AND CYSTS AT THIS LEVEL ARE CONSISTENT WITH INFECTION. ON (B)(6) 2013 FURTHER REVISION NOW SHOWS EXTENSION WITH ILIAC SCREWS AND REVISION ACROSS L3 AND L4 WITH REINTRODUCTION OF PEDICLE SCREWS AT THIS LEVEL AND METAL REMOVAL DOWN TO L2. INTERBODY SPACERS REMAIN AT L4 AND L5. LATERAL VIEW SHOWS FURTHER DEGENERATION AND DISC SPACE COLLAPSE AT L3/4.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGICAL PROCEDURE DUE TO SETSCREW BACKOUT AT L5 AND LEFT S1 AND PSEUDOARTHROSIS. THE SCREW WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350376 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H12D0325

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention